DX-8951f in Treating Patients With Metastatic Stomach Cancer

NCT00017212 | Completed Phase 2

• 4 other identifiers: CDR0000068663DAIICHI-8951A-PRT028SACI-IDD-00-27UTHSC-0015011134
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 6

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage III esophageal cancer; stage IV esophageal cancer; recurrent esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus

Interventions

exatecan mesylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed gastric or gastroesophageal adenocarcinoma * Lymph node involvement and/or distant metastasis * No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach * Measurable disease with indicator lesions outside the field of prior radiotherapy * At least 20 mm by conventional scan OR * At least 10 mm by spiral CT scan * Nonmeasurable lesions include the following: * Primary tumor * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonitis * Cystic lesions * Abdominal masses not confirmed and followed by imaging techniques * No prior treatment for locally advanced or metastatic disease * Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) * Albumin at least 2.8 g/dL * PT or INR no greater than 1.5 times ULN (coumadin independent) Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within the past 6 months Other: * No concurrent serious infection * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No overt psychosis, mental disability, or incompetence that would preclude informed consent * No other life-threatening illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * No concurrent anti-cancer biologic therapy * No concurrent prophylactic colony stimulating factors during first course of therapy Chemotherapy: * Recovered from prior adjuvant chemotherapy * No other concurrent anti-cancer chemotherapy * No other concurrent anti-cancer cytotoxic therapy Endocrine therapy: * Concurrent megestrol for appetite stimulation allowed Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior wide-field radiotherapy to more than 25% of bone marrow * No concurrent anti-cancer radiotherapy Surgery: * At least 4 weeks since prior major surgery and recovered * No concurrent anti-cancer surgery Other: * No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (6)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229-3264, United States

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (1)

• Ajani JA, Takimoto C, Becerra CR, Silva A, Baez L, Cohn A, Major P, Kamida M, Feit K, De Jager R. A phase II clinical and pharmacokinetic study of intravenous exatecan mesylate (DX-8951f) in patients with untreated metastatic gastric cancer. Invest New Drugs. 2005 Oct;23(5):479-84. doi: 10.1007/s10637-005-2907-z.

  PMID: 16133799 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

exatecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Robert L. DeJager, MD, FACP

  Daiichi Sankyo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

CA (1); US (5)